Impact of non-restorative cavity control on proximal carious lesions of anterior primary teeth on the tooth survival and patient-centered outcomes (CEPECO 2): study protocol for a non-inferiority randomized clinical trial

Renata M D Bianchi, Aline M Pascareli-Carlos, Isabela Floriano, Daniela P Raggio, Mariana M Braga, Thais Gimenez, Mariana C Holanda, Gabriela S da Silva, Karina H de Natal, Tamara K Tedesco, Renata M D Bianchi, Aline M Pascareli-Carlos, Isabela Floriano, Daniela P Raggio, Mariana M Braga, Thais Gimenez, Mariana C Holanda, Gabriela S da Silva, Karina H de Natal, Tamara K Tedesco

Abstract

Background: Studies have questioned the necessity of restoring cavitated carious lesion on primary teeth, once the control of biofilm is the most important factor to arrest these lesions. This randomized clinical trial aimed to compare the survival of teeth treated with a non-restorative cavity control (NRCC) compared to resin composite restorations (RCR) on proximal carious lesion in anterior primary teeth, as well as the impact of these treatments on patient-centered outcomes.

Methods: A randomized clinical trial with two parallels arms (1:1) will be conducted. Children between 3 and 6 years old will be selected from the Center of Clinic Research of Pediatric Dentistry of Ibirapuera University (UNIB), a dental trailer (FOUSP) located on Educational Complex Professor Carlos Osmarinho de Lima, the Pediatric Dentistry Clinic of Santa Cecília University and from the Pediatric Dentistry Clinic of University Center UNINOVAFAPI. One hundred and forty-eight teeth will be randomly distributed in two experimental groups: (1) Selective removal of carious tissue and RCR; or (2) NRCC through cavity enlargement using a metallic sandpaper. The primary outcome will be tooth survival after 6, 12, 18 and 24 months. The duration and the cost of dental treatments will be considered for the estimation of the cost-effectiveness of the evaluated treatments. The discomfort reported by the participants will be measured after each treatment using the FIS scale. The participants' satisfaction and perception of the parents/legal guardians will be evaluated through questionnaires. For the primary outcome, Kaplan-Meier's survival and Long-Rank test will be used for comparison between the two groups. All the variables will be modeled by Cox regression with shared fragility. Significance will be considered at 5%.

Discussion: The NRCC could be an option to manage carious lesions on proximal surfaces of primary teeth, and the approach could be well accepted by the children and parents/legal guardians. Trial registration Clinicaltrials.gov registration: NCT03785730, Registered on December 18th 2018, first participant recruited 30/04/2019, https://ichgcp.net/clinical-trials-registry/NCT03785730 . Ethics Reference No: 91569118.8.0000.5597. Trial Sponsor: Universidade Ibirapuera. The Trial was prospectively registered.

Keywords: Deciduous teeth; Dental caries; Non-restorative treatment; Resin composite.

Conflict of interest statement

Tamara K. Tedesco, Thais Gimenez and Mariana M. Braga are members of editorial board of this journal.

Figures

Fig. 1
Fig. 1
Illustration of NRCC treatment. Dashed lines represent the cavity’s size limit to be included in the study (up to one-third of the buccal and/or lingual surfaces involved in the proximal carious lesion). In the first image, we can observe a proximal carious lesion in the upper incisor. This cavity will be enlarged with metallic sandpaper in the buccal and lingual direction, exposing the cavity, as demonstrated in the second image

References

    1. Gimenez T, Bispo BA, Souza DP, Viganó ME, Wanderley MT, Mendes FM, et al. Does the decline in caries prevalence of Latin American and Caribbean children continue in the new century? Evidence from systematic review with meta-analysis. PLoS ONE. 2016;11:e0164903. doi: 10.1371/journal.pone.0164903.
    1. Saravanan S, Madivanan I, Subashini B, Felix JW. Prevalence pattern of dental caries in the primary dentition among school children. Indian J Dent Res. 2005;16(4):140–6. Erratum in: Indian J Dent Res. 2006;17(1):10.
    1. Ardenghi TM, Sheiham A, Marcenes W, Oliveira LB, Bönecker M. Maxillary anterior caries as a predictor of posterior caries in the primary dentition in preschool Brazilian children. J Dent Child (Chic) 2008;75:215–221.
    1. Ramos-Jorge J, Alencar BM, Pordeus IA, Soares ME, Marques LS, Ramos-Jorge ML, et al. Impact of dental caries on quality of life among preschool children: emphasis on the type of tooth and stages of progression. Eur J Oral Sci. 2015;123:88–95. doi: 10.1111/eos.12166.
    1. Halawany HS, Salama F, Jacob V, Abraham NB, Moharib TNB, Alazmah AS, et al. A survey of pediatric dentists' caries-related treatment decisions and restorative modalities—a web-based survey. Saudi Dent J. 2017;29:66–73. doi: 10.1016/j.sdentj.2017.03.001.
    1. Demarco FF, Collares K, Correa MB, Cenci MS, Moraes RR, Opdam NJ. Should my composite restorations last forever? Why are they failing? Braz Oral Res. 2017;31(suppl 1):e56. doi: 10.1590/1807-3107bor-2017.vol31.0056.
    1. Kidd E. Should deciduous teeth be restored? Reflect Cariol Dent Update. 2012;39:159–166. doi: 10.12968/denu.2012.39.3.159.
    1. Levine RS, Pitts NB, Nugent ZJ. The fate of 1,587 unrestored carious deciduous teeth: a retrospective general dental practice based study from northern England. Br Dent J. 2002;193:99–103. doi: 10.1038/sj.bdj.4801495.
    1. Tickle M, Milsom K, King D, Kearney-Mitchell P, Blinkhorn A. The fate of the carious primary teeth of children who regularly attend the general dental service. Br Dent J. 2002;192:219–223. doi: 10.1038/sj.bdj.4801338.
    1. Hu X, Chen X, Fan M, Mulder J, Frencken JE. What happens to cavitated primary teeth over time? A 3.5-year prospective cohort study in China. Int Dent J. 2013;63:183–188. doi: 10.1111/idj.12028.
    1. De Menezes Abreu DM, Leal SC, Mulder J, Frencken JE. Dental anxiety in 6–7-year-old children treated in accordance with conventional restorative treatment, ART and ultra-conservative treatment protocols. Acta Odontol Scand. 2011;69:410–416. doi: 10.3109/00016357.2011.572561.
    1. Leal SC, Bronkhorst EM, Fan M, Frencken JE. Effect of different protocols for treating cavities in primary molars on the quality of life of children in Brazil—1 year follow-up. Int Dent J. 2013;63:329–335. doi: 10.1111/idj.12054.
    1. Mijan M, de Amorim RG, Leal SC, Mulder J, Oliveira L, Creugers NHJ, et al. The 3.5-year survival rates of primary molars treated according to three treatment protocols: a controlled clinical trial. Clin Oral Investig. 2014;18:1061–1069.
    1. Buchanan H, Niven N. Validation of a Facial Image Scale to assess child dental anxiety. Int J Paediatr Dent. 2002;12:47–52.
    1. Furtado GE, Sousa ML, Barbosa TS, Wada RS, Martínez-Mier EA, Almeida ME. Perceptions of dental fluorosis and evaluation of agreement between parents and children: validation of a questionnaire. Cad Saude Publica. 2012;28:1493–1505. doi: 10.1590/S0102-311X2012000800008.
    1. Seifo N, Cassie H, Radford JR, Innes NPT. Silver diamine fluoride for managing carious lesions: an umbrella review. BMC Oral Health. 2019;19:145. doi: 10.1186/s12903-019-0830-5.

Source: PubMed

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